Randomized trial of vitamin B-6 for preventing hand-foot syndrome from capecitabine chemotherapy

Background Capecitabine is an oral fuoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B-6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine. Methods In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the frst 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms. Results Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, -13 percentage points to +25 percentage points). Given our study results, a true beneft from pyridoxine can be excluded. No difference in HFS grades was observed. Limitations Single-institution study. Conclusion Prophylactic pyridoxine (vitamin B-6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS.